Ultramicrosize Griseofulvin

Product NDC
23155-864
11-digit product format
231550864
Labeler code
23155
Product ID
23155-864_db35c070-b434-48f2-8ce8-e902d498459a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Griseofulvin
Dosage form
TABLET
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc d/b/a Avet Pharmaceuticals Inc
Application
ANDA061996
Marketing category
ANDA
Marketing start
2023-06-30
Substance
GRISEOFULVIN
Active strength
250 mg/1
Pharmacologic classes
Decreased Mitosis [PE], Microtubule Inhibition [PE], Tubulin Inhibiting Agent [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A061996-001FULVICIN P/GGRISEOFULVIN, ULTRAMICROSIZE125MGTABLET / ORALABApproved before 1982
A061996-002FULVICIN P/GGRISEOFULVIN, ULTRAMICROSIZE250MGTABLET / ORALABApproved before 1982
A061996-003FULVICIN P/G 165GRISEOFULVIN, ULTRAMICROSIZE165MGTABLET / ORAL1982-04-06
A061996-004FULVICIN P/G 330GRISEOFULVIN, ULTRAMICROSIZE330MGTABLET / ORAL1982-04-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A061996-001AB
A061996-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A061996-001FULVICIN P/G125MGTABLET / ORALABApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A061996-002FULVICIN P/G250MGTABLET / ORALABApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A061996-003FULVICIN P/G 165165MGTABLET / ORAL1982-04-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A061996-004FULVICIN P/G 330330MGTABLET / ORAL1982-04-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A061996-001FULVICIN P/G125MGTABLET / ORALABApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A061996-002FULVICIN P/G250MGTABLET / ORALABApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A061996-003FULVICIN P/G 165165MGTABLET / ORAL1982-04-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A061996-004FULVICIN P/G 330330MGTABLET / ORAL1982-04-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A061996-001FULVICIN P/G125MGTABLET / ORALABApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A061996-002FULVICIN P/G250MGTABLET / ORALABApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A061996-003FULVICIN P/G 165165MGTABLET / ORAL1982-04-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A061996-004FULVICIN P/G 330330MGTABLET / ORAL1982-04-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A061996-001FULVICIN P/G125MGTABLET / ORALABApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A061996-002FULVICIN P/G250MGTABLET / ORALABApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A061996-003FULVICIN P/G 165165MGTABLET / ORAL1982-04-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A061996-004FULVICIN P/G 330330MGTABLET / ORAL1982-04-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A061996-001FULVICIN P/G125MGTABLET / ORALABApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A061996-002FULVICIN P/G250MGTABLET / ORALABApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A061996-003FULVICIN P/G 165165MGTABLET / ORAL1982-04-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A061996-004FULVICIN P/G 330330MGTABLET / ORAL1982-04-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A061996-001FULVICIN P/G125MGTABLET / ORALABApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A061996-002FULVICIN P/G250MGTABLET / ORALABApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A061996-003FULVICIN P/G 165165MGTABLET / ORAL1982-04-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A061996-004FULVICIN P/G 330330MGTABLET / ORAL1982-04-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A061996-001FULVICIN P/G125MGTABLET / ORALABApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A061996-002FULVICIN P/G250MGTABLET / ORALABApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A061996-003FULVICIN P/G 165165MGTABLET / ORAL1982-04-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A061996-004FULVICIN P/G 330330MGTABLET / ORAL1982-04-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A061996-001FULVICIN P/G125MGTABLET / ORALABApproved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A061996-002FULVICIN P/G250MGTABLET / ORALABApproved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A061996-003FULVICIN P/G 165165MGTABLET / ORAL1982-04-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A061996-004FULVICIN P/G 330330MGTABLET / ORAL1982-04-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A061996-001FULVICIN P/G125MGTABLET / ORALABApproved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A061996-002FULVICIN P/G250MGTABLET / ORALABApproved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A061996-003FULVICIN P/G 165165MGTABLET / ORAL1982-04-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A061996-004FULVICIN P/G 330330MGTABLET / ORAL1982-04-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A061996-001FULVICIN P/G125MGTABLET / ORALABApproved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10A061996-002FULVICIN P/G250MGTABLET / ORALABApproved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10A061996-003FULVICIN P/G 165165MGTABLET / ORAL1982-04-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A061996-004FULVICIN P/G 330330MGTABLET / ORAL1982-04-06d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 70 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A061996-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A061996-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A061996-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A061996-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A061996-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A061996-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A061996-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A061996-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A061996-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A061996-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A061996-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A061996-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A061996-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A061996-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A061996-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A061996-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A061996-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A061996-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A061996-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A061996-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A061996-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A061996-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A061996-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A061996-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A061996-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A061996-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A061996-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A061996-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A061996-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A061996-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A061996-003AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A061996-004AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A061996-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A061996-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A061996-003AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A061996-004AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A061996-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A061996-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A061996-003AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A061996-004AB14b0b4de00fa7…

Additional Listing Data#

Finished product
Yes
Brand name base
Ultramicrosize Griseofulvin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GRISEOFULVIN250 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
32HRV3E3D5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
239239Internal RxNorm lookup
242831Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ae369582-2e4c-48a4-ac42-0a77466654fdAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
50874f84-35e6-097e-94d8-7241c05d199fProduct name220190416
024bc7a6-8e89-3d87-480f-f3ffc8f2ad80Product name120140508
0b9696ae-027f-1570-8c58-4178203eb52bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
23155-864-01Ultramicrosize Griseofulvin100 in 1 BOTTLE, PLASTICTABLET1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-864-01EA - Each23155-864649bd54f-06b8-4df8-898e-1f0f82fcc33f12023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-864ULTRAMICROSIZE GRISEOFULVIN (GRISEOFULVIN) TABLET [HERITAGE PHARMACEUTICALS INC D/B/A AVET PHARMACEUTICALS INC]2Current NDC, 1 package rows20230908_ae369582-2e4c-48a4-ac42-0a77466654fd.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ultramicrosize GriseofulvinGRISEOFULVINChartwell RX, LLC.efb8a660-802c-4ca6-bbff-ad7b48b91aef2025-12-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 061996
application number: ANDA061996
Ultramicrosize GriseofulvinGRISEOFULVINHeritage Pharmaceuticals Inc d/b/a Avet Pharmaceuticals Incae369582-2e4c-48a4-ac42-0a77466654fd2025-11-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 061996
application number: ANDA061996
ndc (product): 23155-864
ULTRAMICROSIZE GRISEOFULVINULTRAMICROSIZE GRISEOFULVINChartwell RX, LLC640c489e-f491-4805-a390-ef4be43e261b2025-02-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 061996
application number: ANDA061996
ULTRAMICROSIZE GRISEOFULVINULTRAMICROSIZE GRISEOFULVINAyurax, LLC.43fc5201-d23c-4d83-9247-baefe03774ef2025-02-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 061996
application number: ANDA061996

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
242831griseofulvin 125 MG Oral TabletPSNae369582-2e4c-48a4-ac42-0a77466654fd3
239239griseofulvin 250 MG Oral TabletPSNae369582-2e4c-48a4-ac42-0a77466654fd3
242831griseofulvin 125 MG Oral TabletSCDae369582-2e4c-48a4-ac42-0a77466654fd3
239239griseofulvin 250 MG Oral TabletSCDae369582-2e4c-48a4-ac42-0a77466654fd3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
23155-864-0123155086401100 TABLET in 1 BOTTLE, PLASTIC (23155-864-01) 100 tablet2023-06-30NoNoCurrent